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    CRE Fixed Wire Balloon Dilatation Catheter

    Uploaded by

    maassinger

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd

    CRE Fixed Wire Balloon Dilatation Catheter

    Uploaded by

    maassinger
    41 views2 pages

    Original Title

    CRE-Fixed-Wire-Balloon-Dilatation-Catheter

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    © © All Rights Reserved

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    Copyright:

    © All Rights Reserved
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    41 views2 pages

    CRE Fixed Wire Balloon Dilatation Catheter

    Uploaded by

    maassinger

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 2

    CRE™ Fixed Wire Balloon Dilatation Catheter

    Prescriptive Information

    Refer to the device directions for use for complete instructions on device use.

    Caution/Rx Only:
    Federal Law (USA) restricts this device to sale by or on the order of a physician.
    Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage
    is found, call your Boston Scientific representative. For single use only. Do not reuse, reprocess or resterilize. Reuse,
    reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which,
    in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of
    contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission
    of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the
    patient.
    After use, dispose of product and packaging in accordance with hospital, administrative and/or local government policy.

    Device Description
    The CRE Fixed Wire Balloon Dilatation Catheter is capable of 3 distinct and progressively larger size diameters via
    controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

    Balloon OD Ø Inflation Pressure


    UPN mm F ATM kPA
    M00558330 6-7-8 18-21-24 3-6-10 304-608-1013
    M00558340 8-9-10 24-27-30 3-5.5-9 304-557-912
    M00558350 10-11-12 30-33-36 3-5-8 304-507-811
    M00558360 12-13.5-15 36-40.5-45 3-4.5-8 304-456-811
    M00558370 15-16.5-18 45-49.5-54 3-4.5-7 304-456-709
    M00558380 18-19-20 54-57-60 3-4.5-6 304-456-

    Intended Use/Indications For Use


    The CRE Fixed Wire Balloon Dilatation Catheter is intended for use in adult and adolescent populations to endoscopically
    dilate strictures of the esophagus.

    Contraindications
    None known.

    Precautions
    • The CRE Fixed Wire Balloon Dilatation Catheter should only be used by or under the supervision of physicians trained
    in endoscopic balloon dilatation. A thorough understanding of the technical principles, clinical applications, and risks
    associated with balloon dilatation is necessary before using these devices.
    • If resistance is met during the procedure, do not advance the catheter without first determining the cause of resistance
    and taking remedial action.
    • The CRE Fixed Wire Balloon Dilatation Catheter is designed for use with endoscopes having a minimum working
    channel size of 2.8 mm.
    • The CRE™ Fixed Wire Balloon Dilatation Catheter is supplied sterile by method of ethylene oxide (EO). If catheter
    package is opened or damaged prior to use, do not use the catheter and contact Boston Scientific for replacement.
    • Any use of this device, other than those indicated in these instructions, is not recommended.

    All trademarks are the property of their respective owners.


    ©2017 Boston Scientific Corporation or its affiliates. All rights reserved. ENDO-477301-AA June 2017
    CRE™ Fixed Wire Balloon Dilatation Catheter
    Prescriptive Information

    Refer to the device directions for use for complete instructions on device use.

    Adverse Events
    Possible adverse events that may result from an esophageal balloon dilatation procedure include, but may not be
    limited to:

    • Perforation
    • Hemorrhage
    • Hematoma
    • Sepsis/infection
    • Allergic reaction to contrast medium

    Warranty
    Boston Scientific Corporation (BSC) warrants that reasonable care has been used in the design and manufacture of this
    instrument. This warranty is in lieu of and excludes all other warranties not expressly set forth herein, whether express
    or implied by operation of law or otherwise, including, but not limited to, any implied warranties of merchantability or
    fitness for a particular purpose. Handling, storage, cleaning and sterilization of this instrument as well as other factors
    relating to the patient, diagnosis, treatment, surgical procedures and other matters beyond BSC’s control directly affect
    the instrument and the results obtained from its use. BSC’s obligation under this warranty is limited to the repair or
    replacement of this instrument and BSC shall not be liable for any incidental or consequential loss, damage or expense
    directly or indirectly arising from the use of this instrument. BSC neither assumes, nor authorizes any other person to
    assume for it, any other or additional liability or responsibility in connection with this instrument. BSC assumes no liability
    with respect to instruments reused, reprocessed or resterilized and makes no warranties, express or implied, including but
    not limited to merchantability or fitness for a particular purpose, with respect to such instruments.

    All trademarks are the property of their respective owners.


    ©2017 Boston Scientific Corporation or its affiliates. All rights reserved. ENDO-477301-AA June 2017

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